Confirmatory Combination Therapy Trial Activities definition

Confirmatory Combination Therapy Trial Activities means the activities in a Confirmatory Combination Therapy Trial required by the FDA as a condition for accelerated approval of the Combination Therapy in a particular Indication [*****].
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Confirmatory Combination Therapy Trial Activities means the activities in a Confirmatory Combination Therapy Trial required by the FDA as a condition for granting accelerated approval of the Combination Therapy in a particular Indication. 2. Capitalized terms used in this Amendment but not defined herein shall have the meaning given thereto in the Agreement. 3. All terms and conditions of the Agreement remain unchanged, except where expressly changed by this Amendment. 4. The provisions of Section 17 (Dispute Resolution) and Section 18 (General Provisions) of the Agreement shall apply to this Amendment as if set out in full in this Amendment and as if references in those Section to “this Agreement” are references to this Amendment and references to the “Parties” or a “Party” are references to the Parties or a Party of this Amendment.
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Examples of Confirmatory Combination Therapy Trial Activities in a sentence

  • At each regularly scheduled JSC meeting, each Party shall provide the JSC with regular reports detailing its Development activities for the Combination Therapy, the results of such activities, and if applicable, an update on its spend for the performance of any Confirmatory Combination Therapy Trial Activities.

  • If the Parties perform Confirmatory Combination Therapy Trial Activities in accordance with Section 5.4, within [*****] after the end of each Calendar Quarter, each Party shall provide to the other Party a written report of its actual FTE Costs and Out-of-Pocket Expenses incurred with respect to the performance of such Confirmatory Combination Therapy Trial Activities to be shared by the Parties in accordance with Section 5.4 for such Calendar Quarter.

  • If the Parties perform Confirmatory Combination Therapy Trial Activities in accordance with Section 5.4, within [***] after the end of each Calendar Quarter, each Party shall provide to the other Party a written report of its actual FTE Costs and Out-of-Pocket Expenses incurred with respect to the performance of such Confirmatory Combination Therapy Trial Activities to be shared by the Parties in accordance with Section 5.4 for such Calendar Quarter.

Related to Confirmatory Combination Therapy Trial Activities

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Interscholastic Activities means athletic or non-athletic/academic activities where students compete on a school vs. school basis.

  • Commercial Activities means activities conducted on a commercial basis.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Commercial cannabis activity means the production, cultivation,

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Intrascholastic Activities means athletic or non-athletic/academic activities where students compete with students from within the same school.